Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy (BILANZ)
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ClinicalTrials.gov Identifier: NCT01512446
Recruitment Status :
(low recruitment rate)
First Posted : January 19, 2012
Results First Posted : January 17, 2019
Last Update Posted : February 12, 2019
Evangelisches Krankenhaus Lutherhaus gGmbH
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Prof. Dr. med. Johannes Pfeilschifter, Evangelisches Krankenhaus Lutherhaus gGmbH
The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis.
Condition or disease
Drug: AlendronateDrug: Placebo
Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?
Number of New Osteoporotic Fractures [ Time Frame: From baseline to study termination (mean duration 5.6 months) ]
Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes.
Secondary Outcome Measures :
Mortality [ Time Frame: From baseline to study termination (mean duration 5.6 months) ]
Number of deaths
Combination of New Osteoporotic Fractures and Deaths [ Time Frame: From baseline to study termination (mean duration 5.6 months) ]
Number of participants with a new osteoporotic fracture or death
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Layout table for eligibility information
Ages Eligible for Study:
60 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Postmenopausal women or men > 60 years
DXA T-Score at lumbar spine, total hip or femur neck <-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy
Pretreatment with bisphosphonates for at least four years
Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009
Signed informed consent
Other pharmacological treatment of osteoporosis during the last 48 months
Other bone diseases
Renal insufficiency with a calculated creatinine clearance < 35 ml/min
Diseases of the esophagus, delayed esophageal clearance